WO2021182060A1 - Tissu médical, procédé de production de celui-ci, organe artificiel et endoprothèse couverte - Google Patents

Tissu médical, procédé de production de celui-ci, organe artificiel et endoprothèse couverte Download PDF

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Publication number
WO2021182060A1
WO2021182060A1 PCT/JP2021/006134 JP2021006134W WO2021182060A1 WO 2021182060 A1 WO2021182060 A1 WO 2021182060A1 JP 2021006134 W JP2021006134 W JP 2021006134W WO 2021182060 A1 WO2021182060 A1 WO 2021182060A1
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Prior art keywords
woven fabric
weaving
yarn
medical
warp
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PCT/JP2021/006134
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English (en)
Japanese (ja)
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山田諭
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東レ株式会社
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Priority to JP2021513351A priority Critical patent/JPWO2021182060A1/ja
Publication of WO2021182060A1 publication Critical patent/WO2021182060A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • D—TEXTILES; PAPER
    • D03—WEAVING
    • D03D—WOVEN FABRICS; METHODS OF WEAVING; LOOMS
    • D03D1/00—Woven fabrics designed to make specified articles

Definitions

  • the present invention relates to medical fabrics, manufacturing methods thereof, artificial organs and stent grafts.
  • Aortic aneurysm is a condition in which the aortic wall is abnormally dilated, and the main ones are abdominal aortic aneurysm and thoracic aortic aneurysm. If left untreated, the aortic aneurysm may eventually rupture, causing fatal major bleeding.
  • Stent grafts generally make an incision in an artery distant from the affected area (for example, the brachial artery), and the stent graft is placed in a predetermined position via a catheter inserted from there to the affected area for treatment.
  • Fr French
  • patients with thin blood vessels are out of scope due to the difficulty of inserting a stent graft and cannot take advantage of this treatment. Therefore, there is a need for the design of stent grafts that can be housed in smaller diameter catheters.
  • Patent Document 1 a base fabric that solves the problems of low water permeability and tear strength by adjusting the twist coefficient of the warp and / or the weft is disclosed. Further, a plain woven fabric in which the weaving yarns arranged in the same direction have different crimp ratios and is excellent in low water permeability, mechanical properties and catheter storability is also disclosed (Patent Document 2).
  • Patent Document 1 the medical fabric described in Patent Document 1 is not satisfactory because the adjustment of the twist coefficient of the warp and / or the weft is not sufficient to obtain a sufficient level of low water permeability.
  • the present invention improves the problems of the prior art and is thin enough to allow storage in a small-diameter catheter, yet has durability and low water permeability when stored in a delivery catheter and when a stent is deployed to an affected area. It is an object of the present invention to provide a medical woven fabric which is also excellent in mechanical properties and can be applied to artificial organs such as stent grafts having properties which were not possible by the prior art.
  • the present invention has the following configuration in order to solve such a problem.
  • the tear strength (Fx) in the warp direction and the tear strength (Fy) in the weft direction are both 6N or more, and the ratio of the tear strength (Fx) in the warp direction to the tear strength (Fy) in the weft direction (Fx / The medical woven fabric according to (1), wherein Fy) is 0.8 to 1.25.
  • the maximum difference in height between the concave portion and the convex portion on at least one side of the woven fabric surface is 0 to 20 ⁇ m, (1) or (2).
  • the weaving density (Dx) in the warp direction and the weaving density (Dy) in the weft direction are both 150 threads / 2.54 cm or more, and the weaving density (Dx) in the warp direction is the weaving density in the weft direction (Dy).
  • the medical woven fabric according to any one of (1) to (4), wherein the ratio (Dx / Dy) to) is 0.8 to 1.25.
  • the present invention although it is thin enough to be stored in a small-diameter catheter, it is also excellent in durability, mechanical properties, and low water permeability when it is stored in a delivery catheter and when a stent is deployed to an affected area. It is possible to provide medical fabrics that can be applied to artificial organs such as stent grafts having properties that were not possible with technology.
  • a plain weave that is strong and has excellent abrasion resistance is preferable.
  • a bag-shaped woven fabric may be used in addition to the general flat woven fabric.
  • the medical woven fabric according to the present invention includes yarns in which either the warp yarn or the weft yarn has a different crimp ratio KA, KB (where KA> KB), and the other is a yarn having a crimp ratio (KC). It is characterized by satisfying the equations (1) and (2). 4KC ⁇ KA ⁇ 100 KC (1) 0.5KC ⁇ KB ⁇ 2KC (2)
  • the above-mentioned "including yarns in which either one of the warp yarns or the weft yarns has different crimp ratios KA and KB (where KA> KB)" means a certain weaving yarn arranged in the warp yarn direction and / or the weft yarn direction. However, when it has a certain crimp ratio, it means that weaving yarns having a crimping ratio different from the crimping ratio are arranged and present in the same direction as the weaving yarn.
  • the maximum one is referred to as “crimp rate KA”
  • the minimum one is referred to as “crimp rate KB”
  • the weaving yarn having KA is “weaving yarn A”
  • the weaving yarn having KB is “weaving yarn B”.
  • KC is used.
  • the weaving yarn to have is referred to as "weaving yarn C”.
  • the relationship between the crimp rates KA and KC in the present invention is "4KC ⁇ KA ⁇ 100 KC".
  • the lower limit of the crimp ratio KA in the above formula is "4KC ⁇ KA”, but by setting it preferably “7KC ⁇ KA” and more preferably "10KC ⁇ KA", the yarn having a large crimp ratio can be a warp yarn or a weft yarn.
  • a woven fabric having low water permeability can be obtained by arranging it in any of the fabrics, spreading the yarn bundle, and efficiently covering the woven fabric intersection points.
  • the upper limit of the crimp rate KA is "KA ⁇ 100 KC", but preferably "KA ⁇ 75 KC", more preferably "KA ⁇ 50 KC", so that the yarn having a large crimp ratio can be a warp yarn or a weft yarn.
  • the multifilaments constituting the yarn bundle are lined up linearly in the length direction by efficiently spreading the yarn bundles arranged in one of them and adjacent to each other without interfering with each other. It is possible to cover the woven intersection points. Therefore, it is possible to obtain a woven fabric having low water permeability while maintaining the desired thinness. In addition, it does not get caught when stored and deployed in a small-diameter delivery catheter, and can be suitably used as a medical woven fabric.
  • the relationship between the crimp rates KB and KC is "0.5 KC ⁇ KB ⁇ 2 KC".
  • the lower limit of the crimp rate KB is "0.5 KC ⁇ KB", preferably "0.6 KC ⁇ KB", and more preferably "0.7 KC ⁇ KB”.
  • the crimp ratio KB does not become too lower than the KC, and the KB and KC are maintained evenly, so that even if the weaving yarn C intersects with the weaving yarn A having a high crimp ratio and comes into contact with the weaving yarn A.
  • the weaving yarns A which are multifilaments constituting the yarn bundle, are arranged linearly in the length direction without interfering with the spread weaving yarns A, and it is possible to efficiently cover the woven fabric intersection points.
  • the upper limit of the crimp rate KB is "KB ⁇ 2 KC", preferably "KB ⁇ 1.7 KC", and more preferably "KB ⁇ 1.5 KC".
  • the crimp ratio KB does not become too high as KC, and KB and KC are maintained evenly, so that the weaving yarn B is spread out when the adjacent weaving yarn A having a high crimp ratio is spread.
  • the multifilaments constituting the yarn bundle are arranged linearly in the length direction without interfering with each other, and it is possible to efficiently cover the woven fabric intersection points.
  • the weaving yarn A having a crimp ratio KA and the weaving yarn B having a crimp ratio KB are arranged at a ratio of 1: 1.
  • the "ratio" of the weaving yarn having the crimp ratio KA and the weaving yarn having the crimp ratio KB means the ratio of the number of weaving yarns.
  • the number of weaving yarns is calculated as one unit in which the warp or weft yarn intersects with the weft or warp yarn, and is counted as one when a plurality of weft yarns are inserted in the same mouth.
  • the weaving yarn having a crimp ratio KA and the weaving yarn having a crimp ratio KB are preferably arranged at regular intervals, and more preferably one yarn is alternately arranged or two yarns are alternately arranged.
  • threads with a large crimp ratio are arranged at regular intervals, making it easier to obtain a woven fabric with low water permeability in a thin fabric, improving the balance of mechanical properties, and being durable and excellent in dimensional stability. It can be a woven fabric.
  • the tear strength (Fx) in the warp direction and the tear strength (Fy) in the weft direction are preferably 6N or more, more preferably 6.5N or more, and even more preferably both.
  • it is 7N or more, especially when it is used for a stent graft, it becomes difficult to tear from the sutured part with the stent, and it can be preferably used. If the tear strength is too high, it will not be cut to the desired length and the productivity will decrease, so it is preferably 20 N or less.
  • the ratio (Fx / Fy) of the tear strength (Fx) in the warp direction to the tear strength (Fy) in the weft direction is preferably 0.8 to 1.25, more preferably 0.85 to 1.20. More preferably, when it is set to 0.9 to 1.15, either the warp or weft direction is not easily torn, and the arrangement can be freely set at the time of product design such as the suture site with the stent.
  • the maximum difference in height between the concave portion and the convex portion on at least one side of the woven fabric surface is preferably 0 to 20 ⁇ m, and 0 to 20 ⁇ m. It is more preferably 10 ⁇ m, and even more preferably 0 to 5 ⁇ m.
  • a device such as a stent graft to which the medical fabric of the present invention is attached is housed in the delivery catheter, or when the delivery catheter reaches the affected area and the device is deployed, between the inner wall of the delivery catheter and the device.
  • the existing medical woven fabric of the present invention has excellent storability, durability, and practicality, such as better sliding with both contact surfaces, prevention of tearing of the woven fabric due to friction, and deformation of the delivery catheter and device. It will be a catheter.
  • the fibers constituting the medical woven fabric of the present invention for example, polyamide fibers, polyester fibers, aramid fibers, rayon fibers, polysulphon fibers, ultrahigh molecular weight polyethylene fibers, polyolefin fibers and the like can be used. .. Among them, polyamide fibers and polyester fibers having excellent mass productivity and economy are preferable, and polyester fibers are more preferable because they have excellent biocompatibility.
  • polyamide fiber examples include nylon 6, nylon 66, nylon 12, nylon 46, a copolymerized polyamide of nylon 6 and nylon 66, and a copolymerization of nylon 6 with polyalkylene glycol, dicarboxylic acid, amine, and the like.
  • examples thereof include fibers made of polyamide and the like.
  • Nylon 6 fiber and nylon 66 fiber are particularly excellent in impact resistance and are preferable.
  • polyester fibers include fibers made of polyethylene terephthalate, polybutylene terephthalate, and the like.
  • the fiber may be a copolymerized polyester obtained by copolymerizing polyethylene terephthalate or polybutylene terephthalate with an aliphatic dicarboxylic acid such as isophthalic acid, 5-sodium sulfoisophthalic acid, or adipic acid as an acid component.
  • the fiber is preferably a multifilament yarn because it easily exhibits flexibility and low water permeability, but fibers of other modes can also be used as appropriate.
  • the materials of the warp and weft that make up the medical woven fabric of the present invention may be the same or different, but it is preferable to use the same material in consideration of post-processing and dyeing.
  • both the warp and the weft that make up the medical woven fabric are polyester fibers.
  • the fiber preferably used in the medical woven fabric of the present invention has a total fineness of preferably 10 dtex or more, more preferably 22 dtex or more, still more preferably 33 dtex or more, and as a medical woven fabric, tear strength, breaking strength, and breaking elongation. Sufficient strength can be obtained in terms of mechanical properties such as degree.
  • the total fineness to 220 dtex or less, more preferably 167 dtex or less, and further preferably 110 dtex or less, a medical woven fabric having sufficient thinness and lightness can be obtained.
  • the single fiber fineness is preferably 0.01 dtex to 10 dtex, more preferably 0.1 dtex to 5 dtex, and 0.5 dtex to 2. 5dtex is more preferred.
  • the multifilament yarn constituting the plain woven fabric may be a multifilament yarn obtained by direct spinning, or a so-called ultrafine fiber obtained by desealing the sea-island composite fiber.
  • the weaving density (Dx) in the warp direction and the weaving density (Dy) in the weft direction are preferably 150 threads / 2.54 cm or more, and more preferably 160 threads / 2.54 cm.
  • the weaving density (Dx) in the warp direction and the weaving density (Dy) in the weft direction are preferably 150 threads / 2.54 cm or more, and more preferably 160 threads / 2.54 cm.
  • the number is preferably 240 / 2.54 cm or less.
  • the ratio (Dx / Dy) of the weaving density (Dx) in the warp direction to the weaving density (Dy) in the weft direction is preferably 0.8 to 1.25, more preferably 0.85 to 1.20, and further. By preferably 0.9 to 1.15, there is no difference in mechanical properties in either the warp or weft direction, and the arrangement can be freely set at the time of product design such as the suture site with the stent.
  • the thickness of the plain woven fabric is preferably 90 ⁇ m or less, more preferably 80 ⁇ m or less, still more preferably 70 ⁇ m or less, so that the plain woven fabric can be stored in a small-diameter delivery catheter.
  • the lower limit is preferably about 0.03 ⁇ m, more preferably 1 ⁇ m or more, from the viewpoint of strength and low water permeability.
  • the cover factor of the medical woven fabric of the present invention is preferably 1600 to 4000, more preferably 1800 to 3800, and even more preferably 2000 to 3600. Further, it is particularly preferably 2000 to 2300.
  • the thickness becomes sufficiently thin to be stored in the catheter, and low water permeability can be satisfied, and blood leakage can be prevented.
  • By weaving fine fibers at high density it becomes a woven fabric member that is thin but has excellent mechanical properties and blood leakage resistance.
  • the cover factor of the woven fabric is smaller than 1600, a thin and light woven fabric can be obtained, but it is difficult to obtain low water permeability and it is difficult to satisfy the blood leakage property. Further, when it exceeds 4000, although low water permeability is satisfied, the thickness tends to be thick.
  • the cover factor (Cf) is calculated by the following formula.
  • Cf Dx ⁇ (Nx) 1/2 + Dy ⁇ (Ny) 1/2
  • Dx Warp weaving density (book / 2.54 cm)
  • Dy Weft weaving density (book / 2.54 cm)
  • Nx Total warp fineness (dtex)
  • Ny Total weft fineness (dtex)
  • the water permeability is preferably 70 mL / min / cm 2 or less, more preferably 60 mL / min / cm 2 or less, still more preferably 50 mL / min / cm 2 or less, and is sufficiently low. Water permeability can be obtained, and blood leakage can be prevented when used in a living body, particularly in a blood vessel. The lower limit is actually about 0.01 mL / min / cm 2.
  • the medical woven fabric of the present invention can be produced, for example, as follows.
  • a water jet room, a rapier room, an air jet room, a shuttle room and the like can be appropriately used depending on the application. From the viewpoint of productivity, a water jet room, a rapier room, and an air jet room can be preferably used.
  • the weaving structure is a plain woven fabric, which is woven by interlacing warp threads and weft threads alternately, and is woven by interlacing warp threads and weft threads one by one.
  • a vertical expansion structure in which several weft threads are inserted at the same mouth, a horizontal expansion structure in which several adjacent warp threads are opened at the same opening, or a woven fabric in which several vertical and horizontal threads are arranged side by side like a basket weave may be used.
  • a bag-shaped woven fabric may be used.
  • the tensions of the weaving yarns A and B used for the warp yarns (weft yarns) and the tensions of the weaving yarns C used for the weft yarns (warp yarns) in the direction orthogonal to the weft yarns A and B are respectively.
  • WA, WB, and WC it is preferable to carry out the weaving process under the following conditions. 2WA ⁇ WB (3) 0.7WC ⁇ WB ⁇ 1.5WC (4)
  • the weft (warp) C becomes a fulcrum at the time of weaving, and the warp (weft) B is used as a fulcrum. Since the warp (weft) A is struck in a loose state while being restrained by the (weft) A, the warp (weft) A is folded to express a crimp. In addition, bumping (backlash of weft threads) is suppressed, and an extremely high-density woven fabric can be obtained.
  • WA is preferably 0.05 to 0.6 cN / dtex, and more preferably 0.05 to 0.3 cN / dtex from the viewpoint of forming an appropriate crimp ratio.
  • the lower limit is more preferably 0.06 cN / dtex or more, and particularly preferably 0.07 cN / dtex or more.
  • the WB is preferably 0.5 to 1.5 cN / dtex.
  • the WC is preferably 0.5 to 1.5 cN / dtex.
  • the weaving yarns A and B are warp yarns
  • a method of adjusting the warp yarn feeding speed of the loom and a method of adjusting the weft yarn driving speed can be mentioned.
  • Whether or not the warp tension is actually within the above range during weaving can be confirmed by measuring the tension applied to each warp, for example, between the warp beam and the back roller during operation of the loom with a tension measuring instrument. Can be done.
  • the warp yarn tension of the weaving yarn A may be reduced with respect to the tension of the weaving yarn B, and the desired crimp ratios KA and KB may be appropriately adjusted.
  • the tension when the weft yarns are inserted between the warp yarn openings may be adjusted.
  • the woven fabric may be refined, relaxed, preset, dyed, and finished using a general processing machine.
  • the sea component of the sea island composite fiber which is a composite of the easily soluble sea component and the island component, is acid-treated to embrittle the sea component of the sea island composite fiber.
  • the acid include maleic acid.
  • the treatment conditions are preferably a concentration of 0.1 to 1% by mass, a temperature of 100 to 150 ° C., and a time of 10 to 50 min.
  • the sea component of the sea-island composite fiber embrittled by the acid treatment is eluted by the alkali treatment.
  • the alkali include sodium hydroxide.
  • the treatment conditions are preferably a concentration of 0.5 to 2% by mass, a temperature of 70 to 98 ° C., and a time of 60 to 100 min.
  • At least one side of the woven fabric is subjected to calendar processing in that low water permeability can be achieved or a thin medical woven fabric can be obtained.
  • the calendar processing may be applied to only one side of the woven fabric or both sides. Further, the number of times of calendar processing is not particularly limited, and as long as the unevenness can be sufficiently compressed, it may be performed only once or a plurality of times.
  • the calendar processing temperature is not particularly limited, but is preferably 80 ° C. or higher than the glass transition temperature of the material used, more preferably 120 ° C. or higher, 20 ° C. or higher than the melting point of the material used, and 30 ° C. or higher. It is more preferable that it is low.
  • the calendering temperature is the glass transition temperature of the material used + 80 ° C. or higher, an appropriate degree of compression can be obtained, and a woven fabric having a low air permeability can be easily obtained.
  • the melting point of the material used is as low as ⁇ 20 ° C. or higher, an appropriate degree of compression can be obtained, and the tearing strength of the woven fabric is excellent.
  • the calendar processing temperature is preferably 120 ° C to 200 ° C, more preferably 130 ° C to 190 ° C.
  • the calendar processing temperature is preferably 160 ° C. to 240 ° C.
  • the calendar processing pressure is preferably 0.98 MPa (10 kgf / cm 2 ) or more, more preferably 1.96 MPa (20 kgf / cm 2 ) or more, so that an appropriate degree of compression can be obtained and excellent low water permeability can be obtained.
  • a woven fabric having the above is obtained.
  • it is preferably 5.88 MPa (60 kgf / cm 2 ) or less, more preferably 4.90 MPa (50 kgf / cm 2 ) or less, it is appropriately compressed and the tear strength of the woven fabric becomes excellent.
  • the material of the calendar roll is not particularly limited, but it is preferable that one of the rolls is made of metal.
  • the metal roll can regulate its own temperature and can evenly compress the dough surface.
  • the other roll is not particularly limited, but is preferably made of metal or resin, and in the case of resin, it is preferably made of nylon.
  • the medical woven fabric thus obtained becomes a medical woven fabric having low water permeability and excellent mechanical properties, and can be used as a member of an artificial organ such as a stent graft, an artificial valve, an artificial blood vessel, a dialysis shunt, an artificial dura mater, or an artificial skin. It is preferably used as a graft base material for patch repair materials and the like.
  • the medical woven fabric of the present invention is preferably used for a stent graft, an artificial valve, etc. that is housed and transported in a catheter and placed in an affected area, and is particularly preferably used in a stent graft.
  • the stent graft is placed in the aorta or the like to prevent the aneurysm from rupturing, but if blood leaks from the graft portion made of a woven fabric, blood flow may flow into the aneurysm even after the placement, which may lead to rupture.
  • the medical woven fabric of the present invention which is thin but has low water permeability and mechanical properties that can adapt to the movement of a living body, is most effective when used for a stent graft, especially when used as a graft base material for the stent graft.
  • the medical woven fabric of the present invention When the medical woven fabric of the present invention is used by being placed in a blood vessel such as a stent graft or an artificial valve and in contact with blood, heparin, a heparin derivative or a low molecular weight heparin is supported on the surface of the base material made of the woven fabric. It is preferable that it is.
  • the ratio of sulfur atoms to the abundance of all atoms on the surface of the graft substrate is preferably 3.0% or more and 6.0% or less.
  • the abundance ratio of sulfur atoms to the abundance of all atoms on the surface of the graft substrate can be quantified by performing X-ray electron spectroscopy (XPS) using, for example, "ESCALAB220iXL” manufactured by VG Scientific.
  • XPS X-ray electron spectroscopy
  • the surface of the graft base material referred to here is up to a depth of 10 nm from the measurement surface, which is detected when the X electron escape angle under the XPS measurement conditions, that is, the inclination of the detector with respect to the surface of the graft base material is 90 °. Refers to.
  • Atomic information on the surface of the graft substrate can be obtained from the binding energy values of bound electrons in the substance obtained by irradiating the surface of the graft substrate with X-rays and measuring the energy of the generated photoelectrons, and of each binding energy value.
  • Information on the valence and binding state can be obtained from the peak energy shift. Furthermore, the area ratio of each peak can be used for quantification, that is, the abundance ratio of each atom, valence, and bond state can be calculated.
  • the S2p peak indicating the presence of a sulfur atom is observed in the vicinity of the binding energy value of 161 eV to 170 eV.
  • the area ratio of the S2p peak to the total peak is defined as the abundance ratio (%) of sulfur atoms.
  • the abundance ratio (%) of sulfur atoms to the abundance of all atoms shall be a value calculated by rounding off the second decimal place.
  • heparin heparin derivative or low molecular weight heparin, clinically used leviparin, enoxaparin, parnapalin, sertopalin, dalteparin and tinzaparin can be preferably used.
  • the method of supporting heparin, a heparin derivative or a low molecular weight heparin on the surface of the knitted fabric is not particularly limited, and a method of immobilizing the heparin by covalently bonding with a functional group introduced into the surface of the base material (Patent No. 4152075, Patent). No. 3497612, Japanese Patent Publication No. 10-513074) and a method of immobilization by ionic bonding with a positively charged cationic compound introduced into the surface of a base material (Japanese Patent Publication No. 60-041947, Japanese Patent Publication No. 60-041947).
  • Known methods such as Kosho 60-047287, Patent No. 4273965, and Japanese Patent Application Laid-Open No.
  • a sustained-release type surface support in which heparin is bound by an ionic bond is preferable in that it exhibits antithrombotic properties in the period until it is covered by the new intima and does not inhibit the coating by the new intima.
  • the method described in 2015/080177 is particularly preferably used.
  • the number of filaments was measured in accordance with "8.4 Number of filaments" of JIS L 1013: 2010 "Chemical fiber filament yarn test method".
  • Crimp rate was measured in accordance with "8.7 Thread Weaving Shrinkage Rate B Method" of JIS L 1096: 2010 "Fabric Test Method for Woven Fabrics and Knitted Fabrics".
  • the sample was placed on a flat table, and the threads A1 and B1 having different crimp rates were placed adjacent to each other, excluding unnatural wrinkles and tension, and marked at a distance of 200 mm at three different points.
  • the thread inside the mark is unwound to make a disassembled thread, and the length stretched straight under the initial load specified in 5.1 of JIS L 1013: 2010 is measured, the average value is calculated, and the change length is calculated. bottom.
  • the change length was calculated by measuring the thread C orthogonal to the threads A1 and B1 in the same manner.
  • Cutting the woven fabric in the warp direction and the weft direction in the thickness direction means cutting at the center of the weaving thread A or the center of the weaving thread C.
  • the same measurement was performed on the surface on the opposite side of the woven fabric, and the value of the surface on which the maximum difference in the height of the uneven portion was smaller was taken as the maximum difference in the height of the uneven portion on the surface of the woven fabric.
  • a 1 cm square sample fragment was prepared by cutting a medical fabric.
  • a 1 cm square plain woven sample was sandwiched between two punched donut-shaped packings having a diameter of 0.5 cm and having a diameter of 3 cm so that liquid would not pass through other than the punched portion, and this was stored in a housing for a circular filtration filter.
  • Reverse osmosis membrane filtered water at a temperature of 25 ° C. was passed through this circular filtration filter for 2 min or more until the sample fragment was sufficiently hydrated. Under the conditions of a temperature of 25 ° C.
  • total external pressure filtration of the reverse osmosis membrane filtered water was performed for 30 seconds, and the permeation amount (mL) of water permeating the portion having a diameter of 1 cm was measured.
  • the permeation amount is obtained by rounding off the first decimal place, and the permeation amount (mL) is converted into the value per unit time (min) and the effective area (cm 2 ) of the sample fragment, and the water permeation at a pressure of 120 mmHg (16 kPa) is obtained. Performance was measured. The two samples were measured and the average value was calculated.
  • the weaving tension of the warp was measured by a tension measuring device between the warp beam and the back roller, and the tension applied to each warp was measured. During the weaving operation, measurements are taken for 30 seconds at two locations (both ears) 5 cm from the ears to the center of the fabric and one location at the center of the fabric, and the average of the maximum values at each location is averaged. The weaving tension was set to. As for the weaving tension of the weft, the tension of the weft at the time of weaving into the woven fabric was measured with a tension measuring device. The maximum value of 20 picks measured during the weaving operation was taken as the weaving tension of the weft.
  • Example 1 33dtex, 24-filament polyethylene terephthalate fiber as the raw yarn of the crimp ratio KA weaving yarn (WA), and 33dtex, 24-filament polyethylene terephthalate fiber as the raw yarn of the crimp ratio KB weaving yarn (WB) are used as the warp yarn.
  • the raw yarn of the weaving yarn (WC) having a crimp ratio of KC a polyethylene terephthalate fiber having 33 dtex and 24 filaments was used as the weft.
  • the tension of the weaving yarn WA is 0.2 cN / dtex
  • the tension of the weaving yarn WB is 1.0 cN / dtex
  • the tension of the weaving yarn WC is 1.0 cN / dtex.
  • a plain weave was obtained by weaving with a plain weave structure that was interlaced. After that, it is refined using an open soaper and heat-set at 185 ° C. ⁇ 30 sec using a pin tenter. Got The thickness, maximum difference in unevenness, tear strength, and water permeability of the obtained plain woven fabric were evaluated by the above method.
  • Table 1 shows the characteristics of the obtained plain woven fabric. Since it can be stored and deployed in a small-diameter delivery catheter and has an excellent low water permeability, it is considered that it can be a good medical device with almost no blood leakage even after transplantation.
  • Example 2 33dtex, 24-filament polyethylene terephthalate fiber as the raw yarn of the crimp ratio KA weaving yarn (WA), and 33dtex, 24-filament polyethylene terephthalate fiber as the raw yarn of the crimp ratio KB weaving yarn (WB) are used as the warp yarn.
  • a polyethylene terephthalate fiber having 33 dtex and 24 filaments was used as the weft.
  • the tension of the weaving yarn WA is 0.2 cN / dtex
  • the tension of the weaving yarn WB is 1.0 cN / dtex
  • the tension of the weaving yarn WC is 1.0 cN / dtex.
  • a plain weave was obtained by weaving with a plain weave structure that was interlaced. After that, it is refined using an open soaper and heat-set at 185 ° C. ⁇ 30 sec using a pin tenter. Got The thickness, maximum difference in unevenness, tear strength, and water permeability of the obtained plain woven fabric were evaluated by the above method.
  • Table 1 shows the characteristics of the obtained plain woven fabric.
  • the plain fabric is slightly inferior in workability when sutured to a stent, it can be stored and deployed in a small-diameter delivery catheter, and has a good low water permeability. Therefore, even if it is transplanted. It is considered that a good medical device with almost no blood leakage can be obtained.
  • Example 3 33dtex, 24-filament polyethylene terephthalate fiber as the raw yarn of the crimp ratio KA weaving yarn (WA), and 33dtex, 24-filament polyethylene terephthalate fiber as the raw yarn of the crimp ratio KB weaving yarn (WB) are used as the warp yarn.
  • a polyethylene terephthalate fiber having 33 dtex and 24 filaments was used as the weft.
  • the tension of the weaving yarn WA is 0.2 cN / dtex
  • the tension of the weaving yarn WB is 1.0 cN / dtex
  • the tension of the weaving yarn WC is 0.7 cN / dtex.
  • a plain weave was obtained by weaving with a plain weave structure that was interlaced. After that, it is refined using an open soaper and heat-set at 185 ° C. ⁇ 30 sec using a pin tenter. Got The thickness, maximum difference in unevenness, tear strength, and water permeability of the obtained plain woven fabric were evaluated by the above method.
  • Table 1 shows the characteristics of the obtained plain woven fabric.
  • the plain woven fabric has a slight resistance to storage and deployability in a small-diameter delivery catheter, but it is ⁇ , and since sufficient low water permeability is obtained, there is almost no blood leakage even after transplantation. Medical devices are expected to be obtained.
  • Example 4 33dtex, 24-filament polyethylene terephthalate fiber as the raw yarn of the crimp ratio KA weaving yarn (WA), and 33dtex, 24-filament polyethylene terephthalate fiber as the raw yarn of the crimp ratio KB weaving yarn (WB) are used as the warp yarn.
  • a polyethylene terephthalate fiber having 33 dtex and 24 filaments was used as the weft.
  • the tension of the weaving yarn WA is 0.2 cN / dtex
  • the tension of the weaving yarn WB is 1.0 cN / dtex
  • the tension of the weaving yarn WC is 1.0 cN / dtex.
  • a plain weave was obtained by weaving with a plain weave structure that was interlaced. After that, it is refined using an open soaper and heat-set at 185 ° C. ⁇ 30 sec using a pin tenter. Got The thickness, maximum difference in unevenness, tear strength, and water permeability of the obtained plain woven fabric were evaluated by the above method.
  • Table 1 shows the characteristics of the obtained plain woven fabric.
  • the plain fabric is slightly inferior in workability when sutured to a stent, it can be stored and deployed in a small-diameter delivery catheter, and has a good low water permeability. Therefore, even if it is transplanted. It is considered that a good medical device with almost no blood leakage can be obtained.
  • Example 5 33dtex, 24-filament polyethylene terephthalate fiber as the raw yarn of the crimp ratio KA weaving yarn (WA), and 33dtex, 24-filament polyethylene terephthalate fiber as the raw yarn of the crimp ratio KB weaving yarn (WB) are used as the warp yarn.
  • a polyethylene terephthalate fiber having 33 dtex and 24 filaments was used as the weft.
  • the tension of the weaving yarn WA is 0.5 cN / dtex
  • the tension of the weaving yarn WB is 1.0 cN / dtex
  • the tension of the weaving yarn WC is 1.0 cN / dtex.
  • a plain weave was obtained by weaving with a plain weave structure that was interlaced. After that, it is refined using an open soaper and heat-set at 185 ° C. ⁇ 30 sec using a pin tenter. Got The thickness, maximum difference in unevenness, tear strength, and water permeability of the obtained plain woven fabric were evaluated by the above method.
  • Table 1 shows the characteristics of the obtained plain woven fabric. Since the storage and deployability in a small-diameter delivery catheter is ⁇ and sufficient low water permeability is obtained, it is possible to obtain a medical device that does not cause blood leakage, which is a problem even at the time of transplantation. Conceivable.
  • Example 6 The plain woven fabric of Example 1 was subjected to calendar processing (processing conditions: cylinder processing, temperature 170 ° C., pressure 2.45 MPa (25 kgf / cm 2 , speed 20 m / min) twice on one side of the woven fabric, and the warp density was 185. A plain woven fabric having a weft density of 185 threads / 2.54 cm and a cover factor of 2125 was obtained. Evaluated by method.
  • Table 1 shows the characteristics of the obtained plain woven fabric.
  • the plain woven fabric has excellent storage and deployability in a small-diameter delivery catheter, and has a particularly excellent low water permeability. Therefore, a particularly good medical device that does not cause blood leakage even when transplanted is available. It is thought that it will be obtained.
  • the tension of the weaving yarn WA is 0.05 cN / dtex
  • the tension of the weaving yarn WB is 1.0 cN / dtex
  • the tension of the weaving yarn WC is 1.0 cN / dtex.
  • a plain weave was obtained by weaving with a plain weave structure that was interlaced. After that, it is refined using an open soaper and heat-set at 185 ° C. ⁇ 30 sec using a pin tenter. Got The thickness, maximum difference in unevenness, tear strength, and water permeability of the obtained plain woven fabric were evaluated by the above method.
  • Table 2 shows the characteristics of the obtained plain woven fabric.
  • the plain woven fabric had sufficient tear strength and water permeability, but because it was thick, it was difficult to fold, and it interfered greatly with the inside of the small-diameter delivery catheter, so it could be stored and deployed in the small-diameter delivery catheter. It was difficult ⁇ , and it was insufficient as a medical fabric.
  • the tension of the weaving yarn WA is 0.2 cN / dtex
  • the tension of the weaving yarn WB is 1.0 cN / dtex
  • the tension of the weaving yarn WC is 0.4 cN / dtex.
  • a plain weave was obtained by weaving with a plain weave structure that was interlaced. After that, it is refined using an open soaper and heat-set at 185 ° C. ⁇ 30 sec using a pin tenter. Got The thickness, maximum difference in unevenness, tear strength, and water permeability of the obtained plain woven fabric were evaluated by the above method.
  • Table 2 shows the characteristics of the obtained plain woven fabric.
  • the plain woven fabric had sufficient tear strength and water permeability, but because it was thick, it was difficult to fold, and it interfered greatly with the inside of the small-diameter delivery catheter, so it could be stored and deployed in the small-diameter delivery catheter. It was difficult (x) and was insufficient as a medical fabric.
  • the tension of the weaving yarn WA is 0.1 cN / dtex
  • the tension of the weaving yarn WB is 1.0 cN / dtex
  • the tension of the weaving yarn WC is 0.3 cN / dtex.
  • a plain weave was obtained by weaving with a plain weave structure that was interlaced. Then, it was smelted using an open soaper and desealed. Maleic acid was used as the acid, and the treatment conditions were a concentration of 0.2% by mass, a temperature of 130 ° C., and a time of 30 min. Sodium hydroxide was used as the alkali, and the treatment conditions were a concentration of 1% by mass, a temperature of 80 ° C., and a time of 40 min.
  • the weaving fineness after the desealing treatment was calculated to be 35.2 dtex and 630 filaments on the assumption that the sea was completely desealed. Then, the heat was set at 185 ° C. ⁇ 30 sec using a pin tenter to obtain a plain woven fabric having a warp density of 238 threads / 2.54 cm, a weft density of 230 threads / 2.54 cm, and a cover factor of 2777. The thickness, maximum difference in unevenness, tear strength, and water permeability of the obtained plain woven fabric were evaluated by the above method.
  • Table 2 shows the characteristics of the obtained plain woven fabric.
  • the plain woven fabric has sufficient tear strength, sufficient water permeability, and a thin thickness, but it is difficult (x) to be stored and deployed in a small-diameter delivery catheter due to a large resistance to being caught, and as a medical woven fabric. It was inadequate.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Textile Engineering (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Woven Fabrics (AREA)

Abstract

Afin de fournir un tissu médical présentant d'excellentes caractéristiques mécaniques et une faible perméabilité à l'humidité, la présente invention concerne un tissu médical qui comprend un tissu à armure toile et dans lequel un fil parmi le fil de trame ou le fil de chaîne comprend des fibres ayant des taux de frisure différents (KA, KB où KA > KB), l'autre comprend des fibres ayant un taux de frisure (KC), et les formules (1) et (2) indiquées ci-dessous sont respectées. Ce tissu médical est suffisamment mince pour être logé dans un cathéter ayant un petit diamètre, présente une excellente durabilité, une faible perméabilité à l'humidité, et des caractéristiques mécaniques lorsqu'il est logé dans un cathéter de pose et lors du déploiement d'une endoprothèse dans une zone affectée, et peut être utilisé de façon appropriée dans des organes artificiels tels que des endoprothèses ouvertes ayant des caractéristiques qui n'étaient pas possibles dans l'état de la technique.　Formule (1) : 4 KC ≤ KA ≤ 100 KC. Formule (2) : 0,5 KC ≤ KB ≤ 2 KC.
PCT/JP2021/006134 2020-03-09 2021-02-18 Tissu médical, procédé de production de celui-ci, organe artificiel et endoprothèse couverte WO2021182060A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05237140A (ja) * 1991-02-27 1993-09-17 Seiren Co Ltd 人工血管およびその製造方法
WO2017126009A1 (fr) * 2016-01-18 2017-07-27 旭化成株式会社 Tissu médical
WO2019150937A1 (fr) * 2018-01-30 2019-08-08 東レ株式会社 Tissu à armure unie, procédé pour le fabriquer et endoprothèse
WO2019208262A1 (fr) * 2018-04-26 2019-10-31 東レ株式会社 Tissu tubulaire et matériau de base à usage médical mettant en œuvre un tel tissu tubulaire

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH05237140A (ja) * 1991-02-27 1993-09-17 Seiren Co Ltd 人工血管およびその製造方法
WO2017126009A1 (fr) * 2016-01-18 2017-07-27 旭化成株式会社 Tissu médical
WO2019150937A1 (fr) * 2018-01-30 2019-08-08 東レ株式会社 Tissu à armure unie, procédé pour le fabriquer et endoprothèse
WO2019208262A1 (fr) * 2018-04-26 2019-10-31 東レ株式会社 Tissu tubulaire et matériau de base à usage médical mettant en œuvre un tel tissu tubulaire

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